Trying for a bounce with clinical news:
>>SAN MATEO, Calif., May 14 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) today announced the initiation of a U.S. Phase 2 trial combining ZADAXIN®, the Company's immune system enhancer (ISE), with transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC), the most prevalent primary liver cancer. TACE is a procedure by which chemotherapy, in this case the drug cisplatin, is infused directly to the tumor site rather than administered systemically. The principle investigator for the trial is Dr. Robert Gish of California Pacific Medical Center, in San Francisco.
A phase 2 U.S. trial was initiated in January combining ZADAXIN with radio frequency ablation (RFA), a process which destroys tumors using radio waves delivered via a probe-bearing needle. TACE and RFA are the two current treatments of choice for HCC when it is not treatable by surgery or liver transplantation. Neither TACE nor RFA, however, achieves more than modest success when used alone.
The open label, randomized, controlled TACE trial has the same study design as the RFA trial: to evaluate whether ZADAXIN-enhanced immune response may contribute to the effectiveness of tumor therapy with TACE. In the trial, patients will be randomized in equal numbers to one of two treatment arms, TACE alone or TACE plus ZADAXIN. They will receive treatment for 6 months, followed by a 12-month observation period. Primary endpoints will be tumor response -- the number of patients with undetectable tumors versus those with metastases or new tumor growth -- and patient survival. A secondary endpoint will be the number of patients who become eligible for liver transplantation due to a reduction of tumor burden.
Hepatocellular carcinoma accounts for more than 80% of all primary liver tumors and is the most prevalent malignancy in the world, linked closely to chronic hepatitis B or chronic hepatitis C infection. In the U.S., there are some 4,000 to 6,000 cases of HCC diagnosed each year. The worldwide annual incidence is approximately 1 million new cases. With early identification, HCC is treated with reasonable success by surgery or liver transplantation. However, in later stages, prognosis is poor.
In a previous pilot human study conducted in Italy, patients treated with the combination of ZADAXIN plus TACE showed a statistically significant longer survival time than patients treated with TACE alone, using historical case-matched controls.
``There is growing interest among leading cancer investigators to include ZADAXIN as an immune enhancer component in studies using various treatment regimens,'' said Dr. Alfred R. Rudolph, SciClone's Chief Operating Officer. ``We are now responding to that interest with a cohesive, company-managed U.S. phase 2 cancer program with clear strategic goals. Our goals are to evaluate ZADAXIN as a component' of treatment for different cancers and to determine our optimal disease target and protocol for phase 3 cancer trials and the earliest possible marketing application.''
Dr. Rudolph added that malignant melanoma, for which ZADAXIN trials already have begun in Australia, is likely to become SciClone's next U.S. phase 2 target.<<
snip
Cheers, Tuck |
